DevicePMAs@therightstef:P910031_S015 JSONTXT 11 Projects

Approval for Oracle MegaSonics Five-64(TM) PTCA Catheter. The device, as modified, will be marketed under the trade name Oracle MegaSonics Five-64(TM) PTCA Catheter and is indicated for balloon dilatation of stenotic coronary arteries or bypass grafts for the purpose of improving myocardial perfusion. The catheter is further indicated for use following balloon dilatation as an adjunct to conventional angiographic procedures to provide: 1) an image of the vessel lumen and wall structures and 2) dimensional measurements from the image.